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IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas (IM-CAPABLE Trial)

N/A
Recruiting
Led By Nada Fadul, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months (baseline, month 1, month 3, month 9 and month 15)
Awards & highlights
No Placebo-Only Group

Summary

The goal of this implementation science study is to learn about the experience of receiving and providing cabotegravir + rilpivirine long-acting (CAB+RPV LA) injections as treatment for human immunodeficiency virus (HIV) for people who live a significant distance from an HIV provider. The main questions it aims to answer are: * Is CAB+RPV LA feasible and acceptable to patients and staff? * What barriers and supports exist and have the most impact on receiving and providing CAB+RPV LA? * How does CAB+RPV LA affect HIV stigma, treatment satisfaction, medication adherence and viral suppression? People living with HIV who reside outside of the Omaha, Nebraska metro area and are starting CAB+RPV LA as part of regular medical care for HIV will be invited to participate in this study by completing questionnaires and an interview over 15 months. Clinic staff who are involved in providing HIV care and CAB+RPV LA will also provide input through questionnaires and an interview.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months (baseline, month 1, month 3, month 9 and month 15)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months (baseline, month 1, month 3, month 9 and month 15) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient participants determination of acceptability of CAB+RPV LA implementation
Patient participants determination of feasibility of CAB+RPV LA implementation
Staff participants determination of the acceptability of CAB+RPV LA implementation
+1 more
Secondary study objectives
CAB+RPV LA effect on patient participants reported stigma
CAB+RPV LA effect on patient participants reported treatment satisfaction
Injection Visit Show Rate
+6 more
Other study objectives
Describe patient reported barriers to receiving CAB+RPV LA

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: StaffExperimental Treatment5 Interventions
Staff at the University of Nebraska Medical Center (UNMC) Specialty Care Center or the Nebraska Medicine Grand Island clinic who provide HIV-related care and are involved in this study.
Group II: PatientsExperimental Treatment9 Interventions
Patients receiving care at the University of Nebraska Medical Center (UNMC) Specialty Care Center who live outside of the Omaha metropolitan area and who choose to start CAB+RPV LA as part of clinical care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Qualitative interview
2012
N/A
~210

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,331 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
375 Previous Clinical Trials
470,713 Total Patients Enrolled
Nada Fadul, MDPrincipal InvestigatorUniversity of Nebraska
~37 spots leftby Apr 2026